Blood Donor CVD 5000
ConditionRisk Reduction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
Eligibility criteria
Qualifiers
Age 18 years and older
Good general health as determined by a screening evaluation within 28 days before blood donation
Informed, written consent
Disqualifiers
Diabetes
Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
Heart disease (Hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. Current symptoms of heart disease - dyspnea, angina, orthopnea)
Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
Trial design
Treatments tested in this trial
- Vivotif Typhoid Oral Vaccine
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov